Can Lilly's Olumiant Prickle Xeljanz In India?
Executive Summary
Lilly’s Olumiant has hit the Indian market, upping the level of competition in a rheumatoid arthritis sector that already includes the fellow JAK inhibitor Xeljanz from Pfizer and at least half a dozen biosimilar versions of Humira, among other products. But could pricing cloud Olumiant’s uptake?
Eli Lilly & Co. (India) Pvt. Ltd.’s once-daily oral rheumatoid arthritis (RA) medication Olumiant (baricitinib) had made its debut in India, pitting it against other products including fellow janus kinase (JAK) inhibitor Xeljanz (tofacitinib) from Pfizer Inc. and multiple biosimilar versions of AbbVie Inc.'s Humira (adalimumab), all with a considerable head start in the competitive market.
While Olumiant received significant attention around its pricing plank versus competition in the US - its list price of $25,000 per year was reported as a 60% discount to the anti-TNF therapy Humira and about half the price of Xeljanz - the pricing approach in India, a largely a self-pay market, appears de-linked from the US stance, at least on the face of it and not taking into account any possible trade discounts. For various reasons though, the two markets are not strictly comparable. (Also see "Lilly Prices Olumiant For JAK Battle, But Misses Approval For Higher Dose" - Scrip, 2 Jun, 2018.)
Lilly told Scrip that Olumiant’s registered maximum retail price (MRP) for a one-month course of therapy in India is approximately INR85,000 ($1,154.90), explaining that prices across markets are not comparable and depend on many factors specific to each market.
“The cost of treatment depends on various factors, among which [are] the length of treatment and other factors that are specific to each patient's treatment goals. However, for patients who have been prescribed Olumiant and are facing affordability challenges, a patient support program has been put in place to help them achieve affordable access to Olumiant [in India],” Lilly added.
Xeljanz Access Plans
Significantly, Xeljanz 5mg is available at about INR35,000 for a bottle of 60 tablets in India, going by pricing details on certain online stores, and Pfizer indicated that its access plans could trim the price even further.
Pfizer told Scrip that healthcare systems differ from country to country, and that it works closely with regulatory and other agencies to support rapid access to new and innovative medicines.
“We use innovative access approaches, patient assistance programs, differentiated pricing to help support patient access to the medicines they need. In India, we have access mechanisms in place for Xeljanz that provide this therapy at even lower prices and facilitate access across the country.”
In addition, Pfizer’s TNF inhibitor Enbrel (etanercept), also available in India, remains the “most trusted brand” among rheumatologists in the approved indications and has market leadership in psoriasic arthritis, the US firm’s Indian arm said in its latest annual report.
Adding to the potential complexities around pricing dynamics for newcomer Olumiant is the availability of multiple Humira biosimilar versions in India at around INR22,000-25,000 per dose; patient assistance programs and other discounts have meant that these products can be accessed at much lower prices – Zydus Cadila’s Exemptia (adalimumab ), for one, is available at INR11,000-14,000 for patients who are on a patient assistance program through doctor referrals.
Analysts underscore that pricing remains a key aspect for largely out-of-pocket emerging markets like India, although the dosing convenience of Olumiant - a once-daily oral medication - is seen an important option.
“It remains to be seen if Lilly’s patient assistance program can make a material difference to accessibility,” one analyst said.
Unmet Needs Of RA Patients
Pricing apart, Lilly underscored Olumiant’s pluses and highlighted the unmet need that the therapy is expected to address when asked how it expects to penetrate the Indian market and garner physician attention, given the local availability of already established brands such as Xeljanz.
Lilly said that about four to five million persons in India are estimated to be living with RA and that globally, more than half of the patients with moderate-to-severe RA do not experience remission through conventional drugs and are then put onto more advanced therapies such as biologics. Olumiant, it added, is given as a once-daily oral medication for the treatment of adults with moderate-to-severe active RA who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).
“Olumiant may be used as monotherapy or in combination with methotrexate and reflects an advanced treatment option to help address the unmet needs of RA patients who have had an inadequate response to conventional drugs and continue to experience debilitating, progressive symptoms,” Lilly explained.
While the Olumiant-Xeljanz tussle for market share appears set for take off in India, Informa’s Datamonitor had earlier predicted that in the US and Japan, Xeljanz could lose up to 6% of its patient share to Olumiant, though the estimates were made prior to the June 2018 FDA approval for Olumiant.
“Although the availability of long-term data for Xeljanz in these markets could restrict Olumiant’s uptake, Olumiant’s perceived superior efficacy will drive its uptake,” Datamonitor predicted in a December 2017 report.
Special Warnings And Precautions
Olumiant will be available in India in 4mg and 2mg dosage forms, unlike in the US where the higher of these doses wasn’t approved.
Lilly said that the marketing authorization in India is based on clinical safety and efficacy it submitted and demonstrated in global clinical trials, which were conducted in close to 3,500 patients across 37 countries and in which 131 patients in India participated. The 2mg and 4mg dosages are now approved in more than 50 countries, including India, Japan and EU member states, it noted.
Lilly also clarified that the approved Indian label for Olumiant does not include any boxed warning - the US approval for Olumiant 2mg came with a boxed warning around certain risks including thrombosis.
“There is a detailed section on special warnings and precautions for use [in India] based on the available clinical data on the product and towards supporting the treating physician decision on the usage of the product in [an] appropriate population,” it said.